目的 以注射用芪红脉通为研究对象，确定制剂工艺超滤前最佳除杂技术。方法 考察冷藏、离心、活性炭吸附组合工艺对药液中杂质及有关物质的去除情况。以黄芪总皂苷、黄芪甲苷、羟基红花黄色素A的质量浓度、固含物减少率、蛋白质质量浓度、有关物质检查结果等为评价指标，确定除杂方法的可行性并优化工艺参数。结果 最佳工艺参数为冷藏24 h，离心时间15 min、转速5 000 r/min，活性炭用量0.3%、温度40 ℃、吸附时间30 min、原药液pH值。结论 冷藏、离心和活性炭吸附组合工艺除杂效果显著，可有效去除树脂、蛋白质等杂质。

Objective To optimize the impurity removal technology before ultrafiltration, taking Qihong Maitong Injection (QMI) as the research object. Methods The removal of impurities and related substances by the combined process of refrigeration, centrifugation, and activated carbon adsorption was investigated. Taking the contents of total saponins of astragalus, astragaloside, and hydroxy safflower yellow pigment A, solids reduction efficiency, protein concentration, and related substances inspection as the evaluation indexes, the feasibility of the impurity removal method was definited and the process parameters were optimized. Results The optimized process parameters were as follows: refrigerated for 24 h, centrifugated for 15 min, at 5 000 r/min, activated carbon dosage of 0.3%, temperature 40 ℃, adsorption time 30 min, and the original solution pH value. Conclusion The impurity removal effect of refrigeration, centrifugation, and activated carbon adsorption is significant, which could effectively remove the resin, protein, and other impurities.

科技部重大新药创制项目“中药治疗心脑血管疾病有效成分组（群）的创新药物孵化基地”（2011ZX09401-097）